BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    SURGISIS GUIDED TISSUE REGENERATION MATRIX

    FDA 510(k)
    FDA Class 2 ·Dental

    MUELLER PRO STRIPS

    FDA UDI
    Mueller Sports Medicine, Inc.·00074676019529·PRO STRIPS - 24 EA 2"x5", FOREHEAD

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109520·Zirlux Multi-Unit Abutment 5 mmH for CAMLOG# SC...

    PediPlates

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132135976·PEDIPLATE SOLID SCREW CADDY LID

    NA

    FDA UDI
    STRYKER CORPORATION·04546540494733·U Series MIS Long Curved Attachment

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·January 13, 2015

    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    2.3 OVER THE WIRE TURBO ELITE

    FDA Adverse Event
    Injury ·SPECTRANETICS CORP.·Product code MCW·March 4, 2011

    IDENTITY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 18, 2016

    LANTERN DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·May 19, 2021

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

    5.5MM TI CURVED ROD 45MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015